A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
DeTACT-Africa
A Multi-centre Randomised Controlled Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies Versus First-line ACTs + Placebo for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Africa
1 other identifier
interventional
2,583
8 countries
8
Brief Summary
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedNovember 18, 2025
November 1, 2025
3.5 years
April 9, 2019
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
42 days
Secondary Outcomes (17)
63-day PCR corrected and uncorrected efficacy
63 days
42-day PCR uncorrected efficacy
42 days
Parasite clearance half-life
3 Days
Proportion of subjects with microscopically detectable P. falciparum parasitaemia
Day 3
Fever clearance time
63 Days
- +12 more secondary outcomes
Other Outcomes (13)
Comparison of 63-day vs 42-day PCR corrected and uncorrected efficacy
63 days
Proportions of recurrent infections
63 days
Proportions of specimens collected at baseline with parasites carrying mutations
baseline
- +10 more other outcomes
Study Arms (4)
Artemether-lumefantrine+amodiaquine (AL+AQ)
EXPERIMENTALTriple ACTs
artemether-lumefantrine+placebo (AL+PBO)
ACTIVE COMPARATORACTs
Artesunate-mefloquine+Piperaquine (AS-MQ+PPQ)
EXPERIMENTALTriple ACTs
Artesunate-mefloquine+placebo (AS-MQ+PBO)
ACTIVE COMPARATORACTs
Interventions
AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children. The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days. AQ: is available as dispersible tablets of 40 mg. The weight-based treatment schedule aims for a dosage of approximately 10mg (4.5-15mg)/kg/day amodiaquine for three days.
AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children. The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days. PBO: Placebo tablets for amodiaquine are identical in size, shape and color to the amodiaquine tablets.
AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day. MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day. PPQ: Piperaquine will be administered according to an optimised dosing schedule using tablets of 160 or 500 mg of piperaquine tetraphosphate. The weight-based treatment aims for a dosage of approximately. * 24 mg/kg/day in patients \<25 kg (range 16.0 - 32.0 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 20 - 32 mg/kg per day. * 18 mg/kg/day in patients ≥25 kg (range 15.0 - 29.4 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 16 - 27 mg/kg per day.
AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day. MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day. PBO: Placebo tablets for piperaquine are identical in size, shape and colour to the piperaquine tablets.
Eligibility Criteria
You may qualify if:
- Male or female, aged ≥6 months to \<12 years (For Gambia, Rwanda sites only: ≥6 months)
- Ability to take oral medication
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 1,000/µL to ≤10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000/µL to 200,000/µL)
- Fever defined as ≥ 37.5°C tympanic temperature or a history of fever within the last 24 hours
- Written informed consent by the subject or by parent/guardian in case of children lower than the age of consent and assent if required (per local regulations)
- Willingness and ability of the subjects or parents/guardians to comply with the study protocol for the duration of the study
You may not qualify if:
- Signs of severe malaria (adapted from WHO criteria)
- Patients not fulfilling criteria for severe malaria but with another indication for parenteral antimalarial treatment at the discretion of the treating physician
- Haematocrit \<15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years - Haematocrit \<20% at screening)
- Subjects who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquine within the previous 30 days
- In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days.
- Acute illness other than malaria requiring systemic treatment
- Severe acute malnutrition (in Niger only - only those patients with Severe Acute Malnutrition and complications requiring inpatient nutritional treatment will be excluded)
- Known HIV infection
- Known tuberculosis infection
- For females: post-menarche (For Gambia, Rwanda sites only: females who are pregnant, trying to get pregnant or are lactating)
- History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy
- Previous splenectomy
- Enrolment in DeTACT in the previous 3 months
- Participation in another interventional study in the previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Institut des Sciences et Techniques (INSTech)
Bobo-Dioulasso, Burkina Faso
Kinshasa School of Public Health
Kinshasa, BP 11850 Kin, Democratic Republic of the Congo
Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah
Conakry, B.P. 2649, Guinea
Centre for Malaria and Other Tropical Diseases (CEMTROD)
Ilorin, Kwara State, 1459, Nigeria
Epicentre Niger
Niamey, BP: 13 330, Niger
College of Medicine and Health Sciences, University of Rwanda
Kigali, Rwanda
National Institute For Medical Research (NIMR), Tanga Medical Research Centre
Tanga, Tanzania
MRC Unit The Gambia at LSHTM
Fajara, City of Banjul, 273, The Gambia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 23, 2019
Study Start
September 1, 2020
Primary Completion
March 15, 2024
Study Completion
March 15, 2024
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After completion of trial activities and reporting.
- Access Criteria
- MORU Data Sharing Policy https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing WWARN Terms of Data Access https://www.wwarn.org/tools-resources/terms-data-access
With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with data repositories such as the WorldWide Antimalarial Resistance Network (WWARN, terms of submission here: http://www.wwarn.org/tools-resources/terms-submission) or other researchers to use in the future. All personal information will be anonymised so that no individual can be identified from their treatment records, through interviews, or from mapping data.